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ICU Medical, Inc. recalls Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpa
Recalled August 13, 2014 · FDA recall Z-2165-2014 · ICU Medical
Hazard
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. · FDA Class II
Units
50 units
Sold at
Worldwide Distribution - USA including Oregon and Internationally to Australia.
Description
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Product
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →